Events

NM Implantable Pulse Generator within the Infinity and Proclaim device families 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 St Jude Medical Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2017-RN-01184-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-09-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01184-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Abbott has become aware of instances in which the elective replacement indicator (eri) in some devices has triggered earlier than intended. in these cases, the eri alerts were triggered early due to an error in how the device calculates the actual remaining battery life in the impacted implantable pulse generators (ipg). eri alerts estimate battery life based on programmed device parameters and patient usage and are unique to each patient. importantly, please note that this issue is an error in software calculation and is not an indication of the devices’ actual battery performance. currently, all implanted ipgs within the infinity and proclaim families are affected by this issue.
  • 조치
    1. If an ERI message is displayed on the PC, contact Abbott to obtain the device-specific generator logs and to conduct the ERI Assessment using the steps supplied in the letter. 2. Follow-up communication from Abbott will be provided in order to make appropriate decisions. Either by: - ERI is valid at this time for this device, follow existing information provided by IFU and CP for the elective replacement window for this device. - The device has the appropriate level of battery voltage to provide the existing therapy until the next assessment, which should occur no later than March 2018. During this period, the ERI message will be displayed on the PC at the start of each session and may be dismissed. 3. Abbott will deploy a software upgrade that addresses the errors in calculation causing the inappropriate ERI message. Notification of the availability of this software update will occur through the Apple Public App Store for the PC and through the SJM App Catalogue for the CP.

Device

NM Implantable Pulse Generator within the Infinity and Proclaim device families
  • 모델명 / 제조번호(시리얼번호)
    NM Implantable Pulse Generator within the Infinity and Proclaim device familiesRecall for product correctionARTG Numbers: 277755, 277756 Hazard AlertImplantable Pulse Generator ARTG Numbers: 279015, 279016, 282999, 283000, 289235, 278846, 278847, 278849 and 278850
  • Manufacturer
    St Jude Medical Australia Pty Ltd

Manufacturer

St Jude Medical Australia Pty Ltd
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DHTGA